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ISRCTN
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ISRCTN33749876
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ClinicalTrials.gov identifier
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Public title
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Health promotion in community residences
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Scientific title
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Health promotion in community residences for people with intellectual disabilities: A randomised controlled trial
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Acronym
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N/A
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Serial number at source
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HSN 0802-0339
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Study hypothesis
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The overall aim is to develop and evaluate the effects of a health education programme directed at both staff and residents in community residences for people with intellectual disabilities. Specific objectives are to study improvements in work routines and environment and to study individual effects on dietary and physical activity habits, BMI, waist circumference and quality of life due to the intervention.
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Lay summary
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Ethics approval
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The study was approved by the Regional Ethical Review Board in Stockholm on the 17th of September 2009 (ref: 2009/1332)
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Study design
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Cluster randomised controlled trial
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Countries of recruitment
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Sweden
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Disease/condition/study domain
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Prevention of obesity and chronic diseases related to diet and physical activity among adult people with intellectual disabilities
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Participants - inclusion criteria
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Community residences for adult people with mild or moderate intellectual disabilities, in Stockholm County. A minimum of three residents in each residence who agree to participate.
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Participants - exclusion criteria
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1. Community residences for adult people with severe intellectual disabilities
2. People with intellectual disabilities living on their own
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Anticipated start date
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01/08/2009
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Anticipated end date
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31/12/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use contact details below to request a patient information sheet
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Target number of participants
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160
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Interventions
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32 community residences are selected in Stockholm county and randomised to intervention (n=16) and control (n=16) residences. The intervention group takes part in a health programme including three main components, which will be implemented during 12 months:
1. A health education activity including diet and physical activity targeting residents in community residences. The activity consists of ten sessions which will be carried out in the residences by an external educator.
2. A health ambassador will be appointed among staff members in each residence. The health ambassador will be responsible for health issues and will receive coaching by the project team.
3. The staff in every community residence will come together in 10 sessions to discuss health issues. A discussion leader will be appointed and the group will meet to discuss ten different themes on the basis of a programme material developed specifically for this project.
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Primary outcome measure(s)
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Physical activity will be assessed by pedometry for seven consecutive days. The data will be collected before and after intervention. Parametric and non-parametric tests will be used to compare groups at baseline. Multilevel analysis will be used to evaluate the effects of the intervention outcomes.
Two levels are defined in the analysis:
1. resident
2. residential setting
Linear and logistic regression models will be used to study the effects on the outcome variables.
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Secondary outcome measure(s)
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1. BMI and waist circumference will be measured by the research team
2. Dietary habits will be assessed by use of digital photography taken by residents for three days
3. Quality of life will be assessed by a structured interview
The analysis will be carried out as for the primary outcome.
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Sources of funding
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Stockholm County Council (Folkhälsoanslaget) (Sweden)
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Trial website
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Publications
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1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21144033
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Contact name
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Dr
Liselotte
Schäfer Elinder
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Address
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Karolinska Institutet
Department of Public Health Sciences
Division of intervention and implementation research
Box 170 70
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City/town
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Stockholm
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Zip/Postcode
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104 62
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Country
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Sweden
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Email
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liselotte.schafer-elinder@ki.se
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Sponsor
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Health Care Board and Management (Hälso- och sjukvårdsnämndens förvaltning) (Sweden)
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Address
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Folkhälsoanslaget
Box 6909
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City/town
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Stockholm
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Zip/Postcode
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102 39
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Country
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Sweden
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Email
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cecilia.lindvall@sll.se
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Date applied
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24/05/2010
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Last edited
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30/03/2011
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Date ISRCTN assigned
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30/06/2010
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